Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib

Advanced Renal Cell Carcinoma Clinical Trial

Official title:

An Open-Label, Phase 2 Study to Evaluate the Efficacy and Tolerability of ABT-869 in Subjects With Advanced Renal Cell Carcinoma (RCC) Who Have Previously Received Treatment With Sunitinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486538
• Other study ID #: M06-882
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2007
• Last updated: January 2, 2013
• Start date: June 2007
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Subject has undergone previous nephrectomy.

• Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening.

• Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST.

• ECOG Performance Score of 0-1.

• No history of another active cancer within the past 5 years.Life expectancy of at least 4 months.

• Willing to take adequate measures to prevent pregnancy.

Exclusion Criteria

• Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.

• Subject has untreated brain or meningeal metastases.

• Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.

• Prior use of Avastin is allowed.

• The subject is receiving therapeutic anticoagulation therapy.

• The subject has a history of/or currently exhibits clinically significant cancer related events of bleeding (e.g., hematuria, hemoptysis).

• The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic blood pressure (BP) > 150 mmHg.

• The subject has a history of myocardial infarction within 6 months of Study Day 1.

• The subject has a documented left ventricular (LV) Ejection Fraction < 50%.

• The subject has known autoimmune disease with renal involvement (eg, Lupus).

• Female subjects who are pregnant or breast feeding.

• Subject is receiving anti-retroviral therapy for HIV.

• Subject has a clinically significant uncontrolled condition(s) including but not limited to:

• active uncontrolled infection,

• Class III or IV heart failure as defined by the New York Heart Association functional classification system,

• unstable angina pectoris or cardiac arrhythmia,

• history of adrenal insufficiency,

• psychiatric illness/social situation that would limit compliance with study requirements;

• Active, ulcerative colitis, Crohn's disease, celiadisease or any other conditions that interfere with absorption.

• Subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• ABT-869
One oral dose daily.

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 6566	Vancouver
United States	Site Reference ID/Investigator# 11662	Boston	Massachusetts
United States	Site Reference ID/Investigator# 11663	Boston	Massachusetts
United States	Site Reference ID/Investigator# 5379	Boston	Massachusetts
United States	Site Reference ID/Investigator# 7300	Charleston	South Carolina
United States	Site Reference ID/Investigator# 5384	Chicago	Illinois
United States	Site Reference ID/Investigator# 6796	Houston	Texas
United States	Site Reference ID/Investigator# 5380	Lebanon	New Hampshire
United States	Site Reference ID/Investigator# 5249	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 6278	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 6269	Pittsburgh	Pennsylvania
United States	Site Reference ID/Investigator# 7193	Sacramento	California
United States	Site Reference ID/Investigator# 5243	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		From randomization until patient death or alive at 2 years	No
Secondary	Progression-free rate		Week 16	No
Secondary	Best response rate		From randomization until patient death or alive at 2 years	No
Secondary	Time to tumor progression		From randomization until patient death or alive at 2 years	No
Secondary	Progression free survival		Radiographic evaluation every month, clinical evaluation every 4 weeks	No
Secondary	Overall Survival		Two-year follow-up post study	No